FDA Adverse Event
Injury
Summary report: N
HARMONIC ACE 23CM W ERG HANDLE
MDR report key: 1161677
·
Received September 16, 2008
Report
- Report Number
- 3005075853-2008-01732
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- August 22, 2008
- Report Date
- August 22, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN INCISION HERNIA PROCEDURE, THE TISSUE PAD CAME OFF THE DEVICE. IT LOOKS LIKE THE TISSUE PAD MELTED. THERE IS A PARTIAL PAD ON THE CLAMP ARM. THEY NEVER FOUND THE PAD. THEY USED ANOTHER HARMONIC DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 23CM W ERG HANDLE | LFL | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | GENERATOR| HANDPIECE |